(129 days)
The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:
- Arc™ Catheter .
- Riptide™ Aspiration Tubing .
- Riptide™ Aspiration Pump ●
- Riptide™ Collection Canister with Intermediate Tubing .
The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.
The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.
The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.
The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.
The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Riptide™ Aspiration System to its predicate device, the Penumbra System® and Penumbra Pump MAX™.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists numerous tests conducted on various components of the Riptide™ Aspiration System, with an explicit statement that the device met the acceptance criteria for each. The specific acceptance criteria values are generally not quantified in the "Results" column, but rather stated qualitatively (e.g., "met the acceptance criteria").
Table 1: Acceptance Criteria and Reported Device Performance (Summary)
| Component | Test Category | Individual Test | Acceptance Criteria Statement (from document) |
|---|---|---|---|
| Arc™ Catheter | Biocompatibility | USP Physicochemical | Meets USP Physicochemical (Pass) |
| ISO MEM Elution Using L-929 Mouse Fibroblast Cells | Non-cytotoxic | ||
| ISO Guinea Pig Maximization Sensitization Test | Non-sensitizer | ||
| ISO Intracutaneous Irritation Test | Non-irritant | ||
| ISO Acute Systemic Injection Test | Non-cytotoxic | ||
| ISO Materials Mediated Rabbit Pyrogen | Non-pyrogenic | ||
| ASTM Hemolysis Assay – Direct Contact and Extract Method | Non-hemolytic | ||
| Complement activation C3a and SC5b-9 Assay | The compliment activation of the C3a and SC5b assays were similar for test and comparison articles. | ||
| Thromboresistance Evaluation | The test and control articles exhibited similar thromboresistant characteristics. | ||
| ISO Bacterial Mutagenicity Test - Ames Assay | Non-mutagenic | ||
| ISO in vitro Mouse Lymphoma with Extended Treatment | Non-mutagenic (non-genotoxic and non-clastogenic) | ||
| ISO in vivo Mouse Micronucleus Assay | Non-mutagenic | ||
| Partial Thromboplastin Time | Non-activator (of intrinsic coagulation pathway) | ||
| in vitro Hemocompatibility Assay | No adverse effect on leukocyte or platelet counts. | ||
| Arc™ Catheter | Bench - Microbial | Ethylene Oxide (EO) Residual | Met the acceptance criteria for EO Residual. |
| Ethylene Chlorohydrin (ECH) | Met the acceptance criteria for ECH. | ||
| Bacterial Endotoxin | Met the acceptance criteria for Bacterial Endotoxin. | ||
| Bench - Packaging | Visual Inspection | Met the acceptance criteria for Visual Inspection. | |
| Bubble Leak | Met the acceptance criteria for Bubble Leak. | ||
| Seal Strength | Met the acceptance criteria for Seal Strength. | ||
| Bench - Performance | Lumen Patency | Met the acceptance criteria for Lumen Patency. | |
| Dimensional Inspection | Met the acceptance criteria for Dimensional Inspection. | ||
| Tip Buckling | Met the acceptance criteria for Tip Buckling. | ||
| Injection Flow Rate | Met the acceptance criteria for Injection Flow Rate. | ||
| Suction Flow Rate | Met the acceptance criteria for Suction Flow Rate. | ||
| Vacuum Resistance | Met the acceptance criteria for Vacuum Resistance. | ||
| Air Aspiration Leak | Met the acceptance criteria for Air Aspiration Leak. | ||
| Hub/Shaft Peak Tensile Force | Met the acceptance criteria for Hub/Shaft Peak Tensile Force. | ||
| Coating Integrity | Characterization only. | ||
| Coating Lubricity/Durability | Met the acceptance criteria for Coating Lubricity/Durability. | ||
| Particulate | Met the acceptance criteria for Particulate. | ||
| Kink Resistance | Met the acceptance criteria for Kink Resistance. | ||
| Liquid Leak | Met the acceptance criteria for Liquid Leak. | ||
| Static/Dynamic Burst | Met the acceptance criteria for Static/Dynamic Burst. | ||
| Corrosion Resistance | Met the acceptance criteria for Corrosion Resistance. | ||
| Torque to Failure | Characterization only. | ||
| Riptide™ Aspiration Tubing | Bench - Microbial | Ethylene Oxide (EO) Residual | Met the acceptance criteria for EO Residual. |
| Ethylene Chlorohydrin (ECH) | Met the acceptance criteria for ECH. | ||
| Bioburden Recovery | Met the acceptance criteria for Bioburden Recovery. | ||
| Bioburden | Met the acceptance criteria for Bioburden. | ||
| Bacterial Endotoxin | Met the acceptance criteria for Bacterial Endotoxin. | ||
| Bench - Packaging | Aseptic Presentation | Met the acceptance criteria for Aseptic Presentation. | |
| Seal Width | Met the acceptance criteria for Seal Width. | ||
| Dye Leak | Met the acceptance criteria for Dye Leak. | ||
| Visual Inspection | Met the acceptance criteria for Visual Inspection. | ||
| Bubble Leak | Met the acceptance criteria for Bubble Leak. | ||
| Legibility | Met the acceptance criteria for Legibility. | ||
| Foreign Material | Met the acceptance criteria for Foreign Material. | ||
| Seal Strength | Met the acceptance criteria for Seal Strength. | ||
| Bench - Performance | Dimensional Inspection | Met the acceptance criteria for Dimensional Inspection. | |
| Identification of Heat Shrink Bands | Met the acceptance criteria for Identification of the Heat Shrink Bands. | ||
| Identification of Flow Switch | Met the acceptance criteria for Identification of the Flow Switch. | ||
| Joint Tensile Strength | Met the acceptance criteria for Joint Tensile Strength. | ||
| Leak (Vacuum and Pressure Decay) | Met the acceptance criteria for Leak. | ||
| Degree of Collapse | Met the acceptance criteria for Degree of Collapse. | ||
| Compatibility (Arc™ Catheter & Collection Canister) | Met the acceptance criteria for Compatibility to the Arc™ Catheter and Riptide™ Collection Canister. | ||
| Riptide™ Aspiration Pump | Bench - Performance | Degrees of Tilt | Met the acceptance criteria for Degrees of Tilt. |
| Durability | Met the acceptance criteria for Durability. | ||
| Maximum Vacuum | Met the acceptance criteria for Maximum Vacuum. | ||
| Flow Capacity | Met the acceptance criteria for Flow Capacity. | ||
| Electrical Safety | Met the acceptance criteria for Electrical Safety. | ||
| Electromagnetic Compatibility | Met the acceptance criteria for Electromagnetic Compatibility. | ||
| Riptide™ Collection Canister with Intermediate Tubing | Bench - Packaging | Packaging Integrity | Met the acceptance criteria for Packaging Integrity. |
| Packaging Labeling | Met the acceptance criteria for Packaging Labeling. | ||
| Bench - Performance | Volume Capacity | Met the acceptance criteria for Volume Capacity. | |
| Volume Marking | Met the acceptance criteria for Volume Marking. | ||
| Canister Strength | Met the acceptance criteria for Canister Strength. | ||
| Overfill Protection | Met the acceptance criteria for Overfill Protection. | ||
| Dimensional Inspection | Met the acceptance criteria for Dimensional Inspection. | ||
| Degree of Collapse | Met the acceptance criteria for Degree of Collapse. | ||
| Port Identification | Met the acceptance criteria for Port Identification. | ||
| Compatibility (Riptide™ Aspiration Pump) | Met the acceptance criteria for Compatibility. | ||
| Riptide™ Aspiration System | Bench - System Performance | Simulated Clot Retrieval | Met the acceptance criteria for Simulated Clot Retrieval. |
| Vacuum Pressure | Met the acceptance criteria for Vacuum Pressure. | ||
| Flow Rate | Met the acceptance criteria for Flow Rate. | ||
| Lumen Collapse | The Arc™ Catheter is resistant to Lumen Collapse. | ||
| Usability | Met the acceptance criteria for Usability. |
Study Information:
The provided document describes non-clinical bench testing and non-clinical animal testing. It explicitly states "Not Applicable" for clinical performance data. Therefore, questions related to human reader studies, ground truth establishment for a test set of clinical images, and training set details are not directly addressed in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Bench Testing: The document does not specify the exact sample sizes (number of units tested) for each individual bench test. The nature of these tests often involves a batch of devices or components.
- Animal Testing: The document mentions "a porcine model" but does not specify the number of animals used for the animal testing.
- Data Provenance:
- Bench Testing: Conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, as part of their R&D and regulatory submission process. Location not specified, but the company is based in Irvine, California, USA.
- Animal Testing: Conducted "in a porcine model." Location not specified.
- Retrospective/Prospective: These are non-clinical studies (bench and animal), so the terms retrospective/prospective in the context of human data acquisition do not directly apply. They are inherently prospective in the sense that the tests were designed and executed to evaluate this specific device for its regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The studies described are non-clinical (bench and animal). There is no mention of human expert-established ground truth for a test set of clinical images or data. The "ground truth" for these tests comes from objective measurements against defined standards (e.g., ISO, ASTM, USP standards, or internal specifications) and observations in animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no human expert evaluation of clinical data for ground truth establishment is described, adjudication methods are not relevant to this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states "Performance Data - Clinical: Not Applicable." This means no human reader studies (MRMC or otherwise) were conducted or submitted as part of this 510(k). The device is not an AI-powered system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a medical instrument (aspiration system for stroke), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Ground truth is established by objective measurements against pre-defined engineering specifications, international standards (ISO, ASTM, USP), and validated test methods. For example, "The Arc™ Catheter met the acceptance criteria for EO Residual" means the measured residual levels were below the established safe limits per ISO 10993-7.
- Animal Testing: Ground truth is established through direct observation and measurement in a controlled porcine model, in accordance with "21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies". The goal was to evaluate "safety, efficacy, and usability" and compare it to the predicate device.
8. The sample size for the training set
- Not Applicable. No AI/machine learning component is described for this device, so there is no concept of a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm mentioned, this question is not relevant.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).